Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns
Baxter Healthcare is recalling 0.9% Sodium Chloride Injection due to reports of missing closures and leaks that may compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in an intravenous product, which poses a significant risk of serious injury or infection.
Plain-English summary
Baxter Healthcare Corp. is recalling 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container. The recall involves approximately 597,498 units distributed nationwide. The affected lots are C929844 (Exp 5/31/2015), C926873 (Exp 4/30/2015), and C928630 (Exp 4/30/2015).
The recall was initiated because complaints were received regarding missing closures and/or leaks in the product containers. These defects may compromise the sterility of the injection, which is a critical safety requirement for intravenous medications.
Healthcare providers and facilities that have received this product should stop using the affected lots and contact Baxter Healthcare for instructions on return or disposal. Patients who have received the product should consult their healthcare provider if they have concerns.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Fluids
- Affected units
- 597,498
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: C929844
- Exp 5/31/2015
- C926873
- Exp 4/30/2015
- C928630
- Exp 4/30/2015.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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